Quality Manager, MedSupply Americas
Posted on: August 7, 2022
Quality Manager, MedSupply Americas- 23610 N. 20th Dr., Phoenix
Az 85085 Overall Purpose of The JobThis role is responsible for
overall compliance with all US regulatory guidelines and
certifications, such as ISO 9001, ISO 13485, FDA, DEA, and State
Boards of Pharmacy regulations for current MedSupply facilities in
Arizona and Florida. Compliance activities will ensure quality and
compliance are maintained, including appropriate storage,
manufacturing of kits, distribution, wholesale, import/export
(where applicable) of pharmaceuticals (including controlled
substances) medical devices, and consumables.MedSupply Quality
Manager is a practicing quality professional with thorough
knowledge and experience in the delivery of service excellence in
the healthcare, logistics, or related industry. This role will
support the business in achieving outstanding levels of customer
satisfaction by advising on appropriate quality tools and
techniques, monitoring process performance, and identifying areas
for correction and improvement. The Quality Manager will work with
site management to implement actions to achieve quality and service
excellence targets (KPIs) and be the liaison with customer and
stakeholder representatives on all relevant quality matters. The
Quality Manager will work with the corporate quality team to
undertake the independent process and system audits and will
provide monthly quality status updates to the management team and
stakeholders. The Quality Manager will drive a culture of
evaluation, learning, and improving through gathering insight,
evaluating results, and implementing change. Key
ResponsibilitiesQuality and Regulatory
- After appropriate training in internal processes, the Quality
Manager will serve as Designated Representative / Responsible
Person on State and Federal registrations, where reasonable and
applicable, such as AZ Board of Pharmacy (Wholesaler and
Manufacturer), FDA, DEA.
- Maintain ISO 9001 Certification and ensure continuous
compliance with ISO 9001, while working toward future certification
to ISO 13485.
- Ensure quality, compliance, and good documentation are
maintained, including appropriate storage, manufacturing of kits,
distribution, wholesale, import/export (where applicable) of
pharmaceuticals (including controlled substances) medical devices
- Ensure the quality management system at each site is developed,
deployed, and continually improved meeting MedSupply Corporate
Quality Management Systems, local and global standards, and ISO
- Maintain Quality Document Library. Ensure the documentation and
records are generated, maintained, and retained following Good
Documentation Practices and Data Integrity Principles.
- Receive, acknowledge, report, investigate, analyse root cause,
close the complaints and implement appropriate Corrective and
Preventive actions (CAPAs).
- Ensure all deviations/non-conformances are identified,
reported, investigated, and closed in a regulatory compliant
- Impart training to the personnel on the new procedures as per
the requirement. Identify the training needs for the personnel at
- Responsible to lead all projects related to MedSupply America's
quality and compliance initiatives.
- Conduct supplier qualifications and ensure that quality
agreements are in place with applicable suppliers.
- Ensure that product recalls and returns are managed and
documented as per applicable regulations and SOPs.
- Conducts periodic self-inspection to ensure the compliance and
continual improvement of the quality Management Systems.
- Prepare and analyze the trends for quality aspects i.e.
internal audit, non-conformances, complaints, change controls, and
deviations as per the frequency of MRM. Conduct management review
meetings as per the schedule.
- Liaise with the licensing and certification authorities to
ensure all licenses and certifications are valid and up to
- Work closely with MedAire Quality Manager, MedSupply Corporate
Director of Quality Assurance, and legal team to ensure quality and
compliance initiatives are aligned.
- Manages the regulatory inspections, license applications
(new/renewal), registration of products (pharma/devices), and
response to regulatory queries, notices, and observations in a
compliant manner.Required Skills and Knowledge
- In-depth knowledge of Quality Management Systems specific to
Good Storage and Distribution Practices, ISO 9001 and ISO
- Thorough knowledge of federal, state, and GDP guidelines
related to sourcing, receipt, storage, and distribution of
pharmaceuticals and medical supplies.
- Ability to work in a matrix organization with multiple
- Team player that can work effectively and harmoniously with a
- Excellent communication skills both verbal and written.
- Be personally energetic, dynamic, positive, and enthusiastic
and possess the ability to think laterally and act through reasoned
- Hands-on with a strong sense of urgency, and willing to "roll
- Document control and change control skills.
- Demonstrated attention to detail and ability to handle multiple
tasks and apply sound judgment during demanding situations.
- Demonstrated ability to build strong customer relationships and
deliver customer-centric solutions
- Ability to communicate verbally and in writing with clarity,
brevity, and accuracy
- Demonstrated business and technical writing skills.
- Geographical awareness and cultural sensitivity - take a broad
view when approaching issues, using a global lens
- Proven proficiency in the following Microsoft 365 Office
products: Word, Excel, Teams, Outlook, and PowerPoint. Required
- Minimum 5 years of experience in regulatory compliance for
pharmaceutical wholesalers/distributors/manufacturers or medical
- Minimum 5 years' experience in quality management systems, such
as ISO and/or GDP. ISO Auditor (9001 and/or 13485) experience is a
- Minimum 5 years' experience as Designated Representative /
Responsible Person for pharmaceutical wholesaler/distributor,
manufacturer, or medical device manufacturer.
- A demonstrated commitment to high professional ethical
standards and a diverse workplace. Required Qualifications
- Bachelor's Degree or equivalent work experience
- Certified Auditor (ISO 9001, ISO 13485) preferredRequired
- Excellent written and spoken English Travel/Rotation
- Occasional domestic travel: infrequent international travel may
- Occasional after-hours virtual meetings to accommodate global
time zonesInternational SOS is an equal opportunity employer and
does not discriminate against employees or job applicants based on
race, color, religion, gender, sexual orientation, gender identity,
national origin, age, disability, genetic information, marital
status, amnesty, or status as a covered veteran in accordance with
applicable federal, state, and local laws.
Keywords: MedAire, Phoenix , Quality Manager, MedSupply Americas, Professions , Phoenix, Arizona
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